ACTRN12611000972921
Completed
Phase 2
An Investigator-Initiated Phase 2, Single Centre, Double-Blind, Randomised, Controlled Trial of the Effect of Adalimumab Upon Endothelial Function in Patients with Early and Established Anti-CCP Antibody Positive Rheumatoid Arthritis.
A/Prof Stephen Oakley0 sites60 target enrollmentSeptember 12, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- A/Prof Stephen Oakley
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1: Early Rheumatoid Arthritis: Anti\-CCP (ACPA) positive rheumatoid arthritis of less than 1 year duration by onset of symptoms, age over 18 years, CRP \> 15 mg/L or DAS28\-CRP\>3\.20 within 1 week of enrolment.
- •Group 2: Established Rheumatoid Arthritis: Anti\-CCP (ACPA) positive rheumatoid arthritis of greater than 1 year duration by onset of symptoms, age over 18 years, CRP\>15 mg/L or DAS28\-CRP\>3\.20 within one month of enrolment
Exclusion Criteria
- •1\. Disease Remission (ACR / EULAR 2010 Criteria) or CRP\<15 mg/L
- •2\. Anti\-CCP antibody test negative
- •3\. Serious malignancy within the last 5 years
- •4\. Demyelinating Disease
- •5\. Evidence of previous untreated TB infection
Outcomes
Primary Outcomes
Not specified
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